FDA Device recall Z-0111-2013
EVICEL Fibrin Sealant (Human) Rx Only
- FDA Device
- Class II
- terminated
- Published 2012-10-31
On 2012-10-31 the FDA classified a Class II recall of EVICEL Fibrin Sealant (Human) Rx Only by Ethicon, citing ethicon and Omrix Biopharmaceuticals have received reports of air or gas embolism occuring in association with the use of spray devices employing a pressure regulator to administe….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0111-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-07-02 |
| Published | 2012-10-31 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ethicon |
| Distribution | US |
Product
EVICEL Fibrin Sealant (Human) Rx Only. Manufacturer: Omrix Biopharmaceuticals Ltd. MDA blood bank, Sheba Hospital, Ramat-Gan, POB 888, Kiryat Ono 55000 Israel U.S. License No. 1603. Distributed by: Ethicon, Inc. P.O. Box 151, Somerville, NJ 08876-0151 USA. The Pressure Regulator System is positioned on the floor or on an IV pole and accepts medical gas (compressed air, nitrogen, CO2) from the central hospital system or from medical gas cylinders.
Reason
Ethicon and Omrix Biopharmaceuticals have received reports of air or gas embolism occuring in association with the use of spray devices employing a pressure regulator to administer EVICEL; these events appear to be related to the use of the spray device at higher-than-recommended pressures and/or in close proximity to the tissue surface. The field correction initiated is to provide the recommend
Identifiers
| code_info | To include all lots and product codes for EVICEL and Omrix pressure regulators. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0111-2013%22
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